Efficiency of Two Maxillary Expanders for Maxillary Arch Expansion in Bilateral Cleft Lip and Palate Patients

Ain Shams University20 enrolled

Overview

This randomized controlled trial is designed to compare between Fan expander with palatal springs appliance vs three-way expander regarding the their effectiveness in maxillary expansion in patients with bilateral cleft

The study provides three-dimensional expansion for cleft lip and palate patients. Patients with repaired cleft lip and/or palate have maxillary deficiency and hypoplasia in the three planes of space. Most cases have a normal buccolingual occlusal relation in the molar region between upper and lower jaws, while they manifest arch constriction at the anterior inter-canine width area as well as premaxillary collapse and anterior crossbite. Conventional expansion appliances address only the transverse discrepancy requiring a further step to re-align the premaxilla. So, the aim of the study is to compare the efficiency and the effects of the new design of the three-way palatal expander and the modified fan expander in maxillary arch development in cleft lip and palate patients.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Bilateral Cleft Lip and Palate Maxillary Expansion

Interventions

3D Maxillary Expansion with 3 expansion screwsDEVICE

In patients requiring maxillary expansion, after randomization and allocation for each to receive which expander, appliance will be cemented. In the 3-way group (A), 3 screw activations will be delivered by the care giver to expand the maxillary arch in 3D manner correcting the collapsed arch anteriorly.

3D Maxillary Expansion using modified Fan expander with springsDEVICE

For the fan expander with palatal springs (B) , spring activation will be done by the operator after cemenation intraorally, then the care giver too will just activate one fan screw. Also 3D expansion evaluation was done.

Eligibility

Sex: ALLMin age: 8 YearsMax age: 15 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with age ranging from 8 to 15 years old. * Patients with bilateral cleft lip and palate. * Patients with repaired cleft lip and / or palate. * Patients with fully erupted upper permanent 1st molars. * Patients in the late mixed or early permanent dentition with tapered maxillary arch, requiring palatal expansion as part of their treatment. * Patient's stage of cervical vertebral maturation before or at the growth spurt (CS1-CS4). Exclusion Criteria: * Patients with syndromic cleft lip and palate. * Patients with very bad oral hygiene and active periodontal disease. * Vulnerable groups

Locations (1)

Department of Orthodontics, Faculty of Dentistry, Ain Shams University

Cairo, Abbaseya, Egypt

Outcomes

Primary Outcomes

Maxillary arch development in Anteroposterior dimension

Anterior expansion of the premaxilla in the sagittal plane measured through lateral Cephalograms

Time frame: [Time Frame: 6 - 12 months]

Secondary Outcomes

Inter-canine width expansion in the transverse plane

Inter-canine width expansion in the transverse plane measured on Digital dental models.

Time frame: [Time Frame: 6- 12 months]

Dental changes with expansion

Amount of dental tipping occurring with expansion and amount of expansion and distal movement of maxillary molars

Time frame: [Time Frame: 6- 12 months]

Data from ClinicalTrials.gov

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